+18 straipsnis Įgaliotieji atstovai
---+18 straipsnis 1.
---+18 straipsnis 2.
---+18 straipsnis 3.
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18 straipsnis Įgaliotieji atstovai
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1. Apžvalga
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Reguliavimas |
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18 straipsnis 1.
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Gamintojas gali rašytiniu įgaliojimu paskirti įgaliotąjį atstovą.
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18 straipsnis 2.
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Įgaliotojo atstovo įgaliojimas neapima 13 straipsnio 1–11 dalyse, 13 straipsnio 12 dalies pirmoje pastraipoje ir 13 straipsnio 14 dalyje nustatytų pareigų.
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18 straipsnis 3.
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Įgaliotasis atstovas atlieka gamintojo suteiktame įgaliojime nustatytas užduotis. Įgaliotasis atstovas, gavęs prašymą, rinkos priežiūros institucijoms pateikia įgaliojimo kopiją. Įgaliojimu įgaliotajam atstovui leidžiama atlikti bent šiuos veiksmus:
a)
saugoti 28 straipsnyje nurodytą ES atitikties deklaraciją ir 31 straipsnyje nurodytus techninius dokumentus bent 10 metų po produkto su skaitmeniniais elementais pateikimo rinkai arba palaikymo laikotarpį, priklausomai nuo to, kuris terminas yra ilgesnis, kad rinkos priežiūros institucijos galėtų su jais susipažinti;
b)
jei rinkos priežiūros institucija pateikia pagrįstą prašymą, pateikti visą informaciją ir dokumentus, būtinus produkto su skaitmeniniais elementais atitikčiai įrodyti;
c)
rinkos priežiūros institucijų prašymu bendradarbiauti su jomis dėl visų veiksmų, kurių imamasi siekiant pašalinti produkto su skaitmeniniais elementais, dėl kurio įgaliotajam atstovui suteikti įgaliojimai, keliamą riziką.
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1.1 Nuorodos
1.2 Nustatyti reikalavimai
1.3 Susiję standartai
2. Nustatyti reikalavimai
Reikalavimai
| Šaltinis |
Reikalavimas |
3. Susiję standartai
Standartai
| Šaltinis |
Reikalavimas |
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SCF
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Designated Certifying Official
Description
Mechanisms exist to designate an individual with the authority to make statements of conformity on behalf of the organization.
Possible Solutions & Considerations
Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2
∙ Document applicable regulatory requirements in a checklist
Small Business (10-49 staff) / BLS Firm Size Classes 3-4
∙ Compliance checklist ∙ Annual compliance review
Medium Business (50-249 staff) / BLS Firm Size Classes 5-6
∙ Compliance management program ∙ Regulatory mapping ∙ Compliance calendar
Large Business (250-999 staff) / BLS Firm Size Classes 7-8
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.) ∙ Compliance team
Enterprise (> 1,000 staff) / BLS Firm Size Class 9
∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.) ∙ Dedicated compliance team ∙ Automated compliance monitoring
SCR-CMM
Level 0 Not Performed
Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.
Level 1 Performed Informally
SCR-CMM Level 1 criteria definitions are not available for this control: ▪ A reasonable person would conclude this control requires a structured process. ▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality.
Level 2 Planned Tracked
SCR-CMM Level 2 criteria definitions are not available for this control: ▪ A reasonable person would conclude a well-defined and standardized process is required. ▪ At this level of maturity, the “requirements-driven” nature of performing the control is focused on a localized and/or regionalized implementation, not uniform and consistent across the organization. ▪ Requirements are narrowly scoped for applicability and are primarily derived from compliance obligations (e.g., laws, regulations and contracts).
Level 3 Well Defined
Compliance (CPL) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with CPL domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function. ▪ Standardized Operating Procedures (SOP) associated with CPL domain capabilities are well-documented and kept current by process owners. ▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities. ▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC platform). ▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with CPL domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls). ▪ An implemented and operational capability exists to designate an individual the authority to make statements of conformity on behalf of the organization.
Level 4 Quantitatively Controlled
Utilize SCR-CMM Level 3 criteria definitions: ▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control. ▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.
Level 5 Continuously Improving
Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions: ▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control. ▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies. ▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
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